D-Pharm submits ischemic stroke drug to FDA

Israel's D-Pharm has submitted Investigational New Drug and Special Protocol Assessment packages to the US Food and Drug Administration for  its pivotal Phase III trial of DP-b99 in acute ischemic stroke patients.  The planned Phase III trial is a randomized, double blind,  placebo-controlled study designed to compare the effect on ischemic  stroke outcome between a placebo group and a group of patients treated  with 1mg/kg/day of DP-b99 for four consecutive days. D-Pharm plans to  enroll 770 moderate-to-severely-affected ischemic stroke patients and  initiate the trial later this year.

"I am especially pleased with this achievement, since bringing DP-b99  from design to Phase III really reflects the company's ability to adapt  and mature along with our lead product," said Alex Kozak, president of  D-Pharm.